SANDOZ CLOZAPINE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-03-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
CLOZAPINE
Fáanlegur frá:
SANDOZ CANADA INCORPORATED
ATC númer:
N05AH02
INN (Alþjóðlegt nafn):
CLOZAPINE
Skammtar:
25MG
Lyfjaform:
TABLET
Samsetning:
CLOZAPINE 25MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ATYPICAL ANTIPSYCHOTICS
Vörulýsing:
Active ingredient group (AIG) number: 0122583001; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2022-07-25
Vara einkenni
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PRODUCT MONOGRAPH
PR
SANDOZ CLOZAPINE
Clozapine Tablets
25 mg and 100 mg tablets
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
March 20, 2020
Boucherville, QC, Canada
J4B 1E6
Control No.: 237094
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_Sandoz Clozapine Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
25
DOSAGE AND ADMINISTRATION
..............................................................................
27
OVERDOSAGE
................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
..........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL
INFORMATION..........................................................................
33
CLINICAL TRIALS
..........................................................................................................
34
DETAILED PHARMACOLOGY
..................................................
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